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Safety and Efficacy Study

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ClinicalTrials.gov Identifier: NCT02670863
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : September 8, 2017
Sponsor:
Information provided by (Responsible Party):
Nestlé

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of the experimental formula supplemented with a prebiotic vs the control formula.

Condition or disease Intervention/treatment Phase
Infant Term Birth Other: Experimental Infant Formula Other: Standard Infant Formula Phase 3

Detailed Description:
Randomized, double-blind, controlled interventional clinical trial design. The purpose of this study is to evaluate the safety and efficacy of a new term infant formula supplemented with a prebiotic vs a standard infant formula fed for 150 days to healthy, term infants.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 239 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Safety and Efficacy of a New Term Infant Formula Supplemented With A Prebiotic: a Doubleblind, Randomized, Controlled Trial
Actual Study Start Date : January 21, 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental Infant Formula
Experimental Infant Formula containing a prebiotic
Other: Experimental Infant Formula
Standard bovine milk-based term infant formula supplemented with a prebiotic, fed ad libitum

Active Comparator: Standard Infant Formula
Standard bovine milk-based term infant formula
Other: Standard Infant Formula
Standard bovine milk-based term infant formula, fed ad libitum




Primary Outcome Measures :
  1. Growth [ Time Frame: 150 days ]
    weight gain velocity

  2. Stool Consistency Score [ Time Frame: 150 days ]

Secondary Outcome Measures :
  1. Weight [ Time Frame: 150 days ]
    weight in grams

  2. Average Daily Stool Frequency [ Time Frame: 150 days ]
  3. Fecal Microbiota [ Time Frame: 150 days ]
  4. Fecal Markers [ Time Frame: 150 days ]
  5. Adverse Events [ Time Frame: 150 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 26 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Written Informed Consent
  • Infants whose parent(s)/LAR have reached the legal age of majority in the Philippines
  • Infants whose parent(s)/LAR are willing and able to comply with study requirements
  • Infants whose parent(s)/LAR are able to be contacted by telephone throughout the study
  • Healthy term, singleton infant at birth
  • Between 21 to 26 days post-natal age at enrollment visit
  • Weight-for-length and head circumference-for-age z-scores >/= - 3 and </= +3 according to WHO Child Growth Standards
  • Infants of parent(s)/LAR who have previously made the decision to formula feed their infant at the time of enrollment

Exclusion Criteria:

  • Infants with conditions requiring infant feedings other than those specified in the protocol
  • Infants receiving complementary foods or liquids
  • Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results
  • Infants who are presently receiving or have received medications that could interfere with the interpretation of study results
  • Infants or infants whose parents/LAR cannot be expected to comply with the protocol or with study procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670863


Locations
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Philippines
Asian Hospital and Medical Center
Muntinlupa City, Alabang, Philippines, 1780
Sponsors and Collaborators
Nestlé
Investigators
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Principal Investigator: Elvira M Estorninos, MD Asian Hospital and Medical Center

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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT02670863     History of Changes
Other Study ID Numbers: 14.15.INF
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: September 8, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No